Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief

Trial Title: Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief

NCT ID: NCT05877521

Condition: Chronic Pain
Cancer Pain

Conditions: Official terms:
Chronic Pain
Cancer Pain

Conditions: Keywords:
chronic pain
cancer pain
Mindfulness-oriented Recovery Enhancement
MORE
mindfulness-based interventions
MBIs
Memorial Sloan Kettering Cancer Center
23-082

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: MORE treatments
Description: MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time
Arm group label: 16-hour MORE treatments
Arm group label: 2-hour MORE treatments
Arm group label: 8-hour MORE treatments

Intervention type: Other
Intervention name: Standard of Care for Pain Management
Description: Participants in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers.
Arm group label: Wait List Control (WLC) Usual Care Procedure

Summary: The purpose of this study is to evaluate whether or not mindfulness-based interventions/MBIs may help reduce chronic pain in participants who have cancer-related chronic pain. MBIs are therapeutic programs that use mindfulness meditation practices to help people focus on the present moment, as well as encourage acceptance of thoughts, emotions, and body sensations. The researchers think that an MBI treatment called Mindfulness-oriented Recovery Enhancement (MORE) may help people who are experiencing cancer-related chronic pain.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - English speaking - Age ≥ 18 years or older - A history of cancer with no restrictions placed on type of cancer - Determined to be either no-evidence of disease or stable oncological disease by referring or study physicians/advanced practice providers - Having a pain (musculoskeletal, generalized, or neuropathic) rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week - Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days - Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MORE or WLC - Ability to attend video-call session and a quiet/private location Exclusion Criteria: - Active suicidality or schizophrenia - Plan to initiate palliative radiation or interventional pain procedure within the next 12 weeks - Cognitive impairment preventing completing PRO independently or participate in virtual MORE as evaluated by study clinicians

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Contact:
Last name: Jun Mao, MD, MSCE

Phone: 646-608-8552

Start date: May 16, 2023

Completion date: May 16, 2027

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05877521
http://www.mskcc.org